AuthorisedTherapeutic use (Phase IV)Interventional

Evaluation of the persistency of the preoperative anxiolytic effect of music therapy vs midazolam: electroencephalographic and clinical analysis

This research is investigating whether music therapy or a medication called midazolam is better at helping people relax before surgery. Many people feel nervous before an operation, and this study wants to find the best way to ease those worries. Researchers will use special equipment to look at brain activity, alongside asking people to complete questionnaires about their anxiety levels. They want to see how long any calming effects last and compare the two approaches. The aim is to understand which method is more effective at making patients feel more comfortable and less stressed before their procedure.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Consorci Mar Parc De Salut De Barcelona

Enrolment target

100

Start

05 Dec 2025

Preoperative anxiety

What is this study about?

Feeling anxious before an operation is very common. This study is designed to compare two different ways of helping people relax before they have surgery: listening to music or taking a small dose of a calming medicine called midazolam. The main goal is to see which of these works better at reducing anxiety and how long the calming effect lasts.

Researchers will be looking at brain activity using a special monitor, which can give them an idea of how relaxed or alert someone is. They'll also ask participants to complete some questionnaires that are designed to measure anxiety levels. By doing this, they can get a clear picture of how each method affects a person's feelings and brain state before an operation.

This type of study, often called a 'Phase IV' or 'therapeutic use' study, usually means the treatments being looked at are already approved and in use. The study is trying to understand more about how these treatments work in a real-world setting and compare their effectiveness for a common problem like pre-surgery nerves.

Key takeaways

Compares music therapy and medication for pre-surgery anxiety.
Uses brain activity (EEG) and questionnaires to measure relaxation.
Aims to find out which method works best and for how long.
Looks at adults aged 18 and over.
Standard medical monitoring, like heart rate, will also be done.
You have the option to withdraw from the study at any time.

Who may be eligible?

This study is looking for adults aged 18 and over, with no upper age limit. Both men and women are welcome to take part.

You might be suitable for this study if you are someone who is due to have an operation and typically experiences some anxiety beforehand. The study is open to a wide range of people, as long as they are adults.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you scheduled for an operation?
Are you comfortable with the idea of either listening to music or receiving a calming medicine before surgery?
Are you generally in good health, aside from the condition requiring surgery?
Are you comfortable filling out questionnaires and having your brain activity monitored?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to either receive music therapy or a small dose of midazolam before your surgery. Researchers would use a special monitor on your head to measure your brain activity (EEG) – this is completely painless and non-invasive. You would also be asked to fill out several questionnaires about your anxiety levels before and possibly after your surgery.

Throughout the study, your blood pressure, heart rate, and oxygen levels would also be monitored, which is standard practice before an operation. The research team would also ask for general information about you, such as your age, and details about your surgery, like whether you're staying overnight or going home the same day. They would also keep an eye out for any side effects you might experience and note any medicines you take regularly. The total time for your participation would be around your surgery day.

Potential risks and benefits

Potential benefits of taking part could include receiving an intervention (music or medication) that might help reduce your anxiety before surgery. There are generally low risks associated with music therapy. For midazolam, common potential side effects might include drowsiness or dizziness, which your medical team would monitor closely. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is midazolam?

Midazolam is a medicine often used to help people relax and feel drowsy before medical procedures. It's a type of calming medication.

What is music therapy?

Music therapy, in this study, likely involves listening to specially chosen music designed to help you relax and feel less anxious before your surgery.

Will I know if I'm getting music or medicine?

The study design will determine whether you know which group you are in. Sometimes studies are designed so participants don't know, to ensure fair results.

What is an EEG?

An EEG (electroencephalogram) is a test that measures electrical activity in your brain using small sensors placed on your scalp. It's painless and simply records brain waves.

Will this affect my surgery?

The interventions in this study are aimed at helping you feel more comfortable before surgery and are not expected to negatively affect your surgical procedure itself.